United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-98-022
December 1998
R.E.D. FACTS
Pesticide
Reregistration
Hydramethylnon
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered before November 1, 1984, be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. To implement provisions of the
Food Quality Protection Act (FQPA) of 1996, EPA considers the special
sensitivity of infants and children to pesticides, as well as aggregate exposure
of the public to pesticide residues from all sources, and the cumulative effects
of pesticides and other compounds with common mechanisms of toxicity. The
Agency develops any mitigation measures or regulatory controls needed to
effectively reduce each pesticide's risks. EPA then reregisters pesticides that
meet the safety standard of the FQPA and can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for
its decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case
2585, hydramethylnon.
Use Profile
Hydramethylnon is an insecticide used to control ants, cockroaches,
crickets, and termites. There are 28 end use product formulations that are
either granular baits or ready-to-use gelatin. The use on rangelands or pastures
primarily for Imported Fire ant control, is considered to be a food use and
established tolerances are cited in 40 CFR Section 180.395. Hydramethylnon
completely metabolizes within the body of foraging ruminants so there is an
exemption from the requirement of a tolerance for meat, milk, and meat
byproducts.
Regulatory
Hydramethylnon was first registered as a pesticide in the U.S. in 1980.
-------
History
Human Health
Assessment
As part of the reregi strati on process the Agency issued Data Call-Ins (DCI) for
data needed to support the continued registration of hydramethylnon products.
These DCIs required environmental fate, ecological effects, and toxicological
data. In addition, data to support the agricultural and residential grass use
were requested.
Toxicity
In studies using laboratory animals, hydramethylnon generally has been
shown to be of low acute toxicity. It has been placed in Toxicity Category III
for effects via the oral route of exposure and eye irritation, and Toxicity
Category IV for the dermal and inhalation routes. The Cancer Peer Review
Committee determined that hydramethylnon should be classified as a Group C
carcinogen, a possible human carcinogen, based upon statistically significant
lung adenomas and carcinomas.
Dietary Exposure
People are not likely to be exposed to residues of hydramethylnon either
through their diet or drinking water. There are tolerances for grass orage and
hay by grazing and foraging cattle but there are no food or feed residues and
groundwater contamination from hydramethylnon is unlikely.
Occupational Exposure
Workers are most likely to be exposed to hydramethylnon by application
of the ready-to-use gelatins to kitchen counter tops but these exposures are
minimal. EPA is generally not concerned with occupational risk if MOEs
(margins of exposures) are greater than 100.
Other Considerations
Because hydramethylnon is considered a food use the specific
determinations outlined in FQPA were taken into consideration. Contact by
infants or children with the ready-to-use gelatin product from food preparaton
counter top is unlikely and exposure from drinking water is not expected.
The Agency has not made a determination whether hydramethylnon and
any other pesticide have a common mechanism of toxicity that would require a
cumulative risk assessment. For the purposes of this RED, EPA has
considered only the risks from hydramethylnon. If required, cumulative risks
will be assessed when methodologies for determining common mechanism of
toxicity and for performing cumulative risk assessments are finalized.
Environmental Environmental Fate
Assessment For the currently registered uses of hydramethylnon, the Agency
typically requires an abbreviated set of environmental fate data on hydrolysis,
metabolism, and mobility.
Based on existing data, hydramethylnon is likely to be moderately
persistent to persistent and relatively immobile in terrestrial environments.
-------
Hydramethylnon is stable to abiotic hydrolysis and photodegradation on soil.
It does not exhibit fate and transport characteristics similar to chemicals that
are known to leach to groundwater.
Ecological Effects/Risk
Calculated acute avian risks do not exceed the Level of Concern (LOG).
The Agency concludes that the overall acute impact on freshwater and
terrestrial non-target organisms from the use of hydramethylnon for insect
control will be minimal. The Agency is requiring an avian reproduction study
for confirmatory purposes.
Risk Mitigation The Agency is requiring the use of water resistant gloves and a 12 hour
re-entry interval. The Agency is also establishing the minimum Worker
Protection Standard (WPS) Personal Protective Equipment (PPE) of coveralls,
water-resistant gloves, shoes and socks for early re-entry.
Additional Data EPA is requiring product-specific data including product chemistry and
Required acute toxicity studies, and revised labeling for reregistration. Some additional
ecological effects and environmental fate data are being required for
confirmatory purposes.
Product Labeling
Changes Required
All hydramethylnon end-use products must comply with EPA's current
pesticide product labeling requirements and the water resistant glove
requirement, the 12 hour restricted entry interval, the early entry PPE
requirements and the user safety recommendations below. The following
labeling changes are required.
User Safety Recommendations
! "Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
! "Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
! "Users should remove protective clothing and equipment
immediately after handling this product. Wash the outside of
gloves before removing. Keep and wash protective clothing and
equipment separately from other laundry."
Regulatory The use of currently registered products containing hydramethylnon in
Conclusion accordance with changes specified in this document will not pose unreasonable
risks of adverse effects to humans or the environment. Therefore, all uses of
these products are eligible for reregistration.
-------
Hydramethylnon products will be reregistered once the required product-
specific data, required confirmatory generic data, product specific data,
confidential statements for formula, and revised labeling are received and
accepted by EPA.
For More
Information
EPA is requesting public comments on the RED document for
hydramethylnon during a 60-day time period, as announced in a Notice of
Availability published in the Federal Register. To obtain a copy of the RED
document or to submit written comments, please contact the Pesticide Docket,
Public Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs (OPP), US EPA,
Washington, DC 20460, telephone (703) 305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs.
Printed copies of the RED and Fact Sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), P.O. Box 42419, Cincinnati, OH 45242-2419, telephone at
1-(800) 490-9198; fax (513) 489-8695.
Following the comment period, the hydramethylnon RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, Virginia 22161; telephone at (703) 605-
6000 or 1-(800) 553-6847.
For more information about EPA's pesticide reregi strati on program, the
hydramethylnon RED, or reregi strati on of individual products containing
hydramethylnon, please contact the Special Review and Reregi strati on Division
(7508), OPP, US EPA, Washington, DC 20460, telephone at (703) 308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
(800) 858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm
Eastern Standard Time, Monday through Saturday. Their internet address is:
ace.orst.edu/info/nptn/.
------- |